跳至主要内容
临床试验/NCT02002455
NCT02002455已完成2 期

Preoperative Staging and Dose Escalated Radiotherapy of Prostate Carcinoma

Turku University Hospital2 个研究点 分布在 1 个国家目标入组 26 人开始时间: 2013年12月最近更新:
适应症

试验速览

阶段
2 期
状态
已完成
入组人数
26
试验地点
2
主要终点
Diagnostic accuracy of hybrid PET/MRI with FACBC

研究概览

简要总结

Prostate cancer (PCa) is currently the most common neoplastic disease among men in well-developed countries with 350 000 new cases diagnosed annually in Europe and 4 800 in Finland. Due to widespread use of serum prostate specific antigen (PSA) in asymptomatic men, most patients present initially with localized disease. Radical prostatectomy, radiotherapy (RT) and active surveillance are the most common management options for patients with localized PCa. Proper preoperative staging for patients with adverse features on biopsy who are candidates for radical prostatectomy is urgently needed. For elderly men external beam RT is the preferred modality which can be safely performed utilizing modern techniques such as intensity modulated and image guided radiotherapy (IMRT and IGRT). Since randomized studies suggest a dose response effect beyond 78-80 Gy newer techniques aim at dose escalation provided that toxicity can be controlled. Therefore, ultra high dose IMRT/IGRT requires visualization of intracapsular disease which will receive the highest dose. Taken together, the use of accurate anatomical and functional imaging modalities are essential for planning both nerve sparing radical prostatectomy and ultra high dose IMRT/IGRT Fluorine-18 labeled L-leucine analogue 1-amino-3-fluorocyclobutane-1-carboxylic acid (FACBC) has shown to preferentially accumulate in PCa and its nodal metastases. By assisting in localization of intraprostatic and pelvic disease FACBC with hybrid positron emission tomography/computed tomography (PET/CT) or magnetic resonance imaging (PET/MRI) has potential to improve selection of patients for robot-assisted radical prostatectomy and IMRT/IGRT.

Anatomical MRI at 1.5 Tesla (T) compared with transrectal ultrasound has demonstrated a higher sensitivity for tumor detection but almost the same specificity, stressing the need for additional metabolic MRI. Advanced application of MRI such as proton magnetic resonance spectroscopy (1H MRS), diffusion weighted imaging (DWI) and dynamic contrast enhanced imaging (DCE-MRI) are increasingly being used for detection and characterization of PCa. The use of 3T scanners and multiparametric MRI (mpMRI), consisting of anatomical MRI, DWI, 1H MRS and DCE-MRI, demonstrated very promising result for staging and detection of PCa.

详细描述

Specific aims of the current study are as follows:

i) To determine the sensitivity, specificity and accuracy of multiparametric 3T MRI, (anatomical MRI, DCE-MRI, DWI and 1H MRS) combined with FACBC PET/CT and PET/MRI in correlation with systematic biopsy and whole mount prostatectomy specimens.

ii) To asses the applicability of multiparametric 3T MRI combined with FACBC-PET/CT and PET/MRI for detection of cancer aggressiveness based on Gleason score and PSA.

iii) To develop quantitative and qualitative methods for evaluation of FACBC PET/MRI

iv) To develop and validate an imaging protocol which will become the standard protocol for prostate imaging both for surgical and radiotherapy patients at Turku PET Centre using hybrid PET/MRI

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Diagnostic
盲法
None

入排标准

年龄范围
50 Years 至 85 Years(Adult, Older Adult)
性别
Male
接受健康志愿者

入选标准

  • Age: 50 to 85 years old
  • Language spoken: Finnish or Swedish
  • Diagnosis: Histologically confirmed adenocarcinoma of prostate
  • Adequate histological sampling consisting of at least 3 biopsy samples from each lobe
  • No previous surgical, radiation or endocrine treatment for prostate carcinoma
  • Clinical stage T1c-T3aN0 based on transrectal ultrasound
  • Serum creatinine ≤ 1,5 x upper limit of normal (ULN)
  • Patient agrees to undergo either surgery or external radiotherapy
  • Mental status: Patients must be able to understand the meaning of the study
  • Informed consent: The patient must sign the appropriate Ethical Committee (EC) approved informed consent documents in the presence of the designated staff

排除标准

  • Prior medical history: Patient must have no history of serious cardiovascular, liver or kidney disease
  • Infections: Patient must not have an uncontrolled serious infection
  • No contraindications for MRI (cardiac pacemaker, intracranial clips etc)
  • Patient preference for active surveillance as a method of prostate cancer management

结局指标

主要结局

Diagnostic accuracy of hybrid PET/MRI with FACBC

时间窗: 1 years

By comparing tracer uptake and imaging findings at MRI in each sextant with macroslices obtained at radical prostatectomy sensitivity, specificity, positive and negative predictive value and accuracy will be calculated

次要结局

  • Biochemical relapse free survival (bRFS)(5 years)

研究者

申办方类型
Other Gov
责任方
Principal Investigator
主要研究者

Heikki Minn

Professor

Turku University Hospital

研究点 (2)

Loading locations...

相似试验